Manufacturing Process of Eye Drops – If you are looking for some guidance for the Eye drops manufacturing process, here in this article we share some key points to manufacturing ophthalmic drops. As all, you know about the rising demand of the ophthalmic industry and now everyone wants to invest in the ophthalmic industry. Ophthalmic industry paly a very essential role in the growth rate country.
Today every third person is facing some problem of eye-related such as lazy eye, glaucoma’s onset, moisten dry eyes, etc. The ophthalmic industry grows at the rate of 6.8% a year and is expected to touch $1.8 billion by 2022. So if you want to invest, ophthalmic is the best commercial industry to invest in. Stay with us below this article we share some valuable points for the manufacturing process of ophthalmic drops.
List of Some key Point for Eye Drops Manufacturing Process:
The eye is the most sensitive part of our body any kind of minor mistake can become a serious problem. So everyone should be careful during the manufacturing of ophthalmic drops. Here we discuss some major points regarding the manufacturing of eye preparations.
Keep some point in your mind when you start manufacturing:
- Hier Experienced Technical/Non-Technical Staff
- Types of Eye Preparations
- The dosage form of Eye Preparations
- Equipment and Machinery Required for ophthalmic Drops
- Procedure for manufacturing of ophthalmic Drops
The manufacturing processes should engage the necessities Fof Good Manufacturing Practices. Cross-contamination is a particular concern in ophthalmic manufacturing. From the filtration of water through filling and into the packaging and storing of the final ophthalmic solution all of these things are maintained under the guidance of GMP. Most of the ophthalmic products in liquid, which means that most of the ophthalmic drops manufacturing process starts with water for injection (WFI).
In-process controls during the manufacturing of eye drops should include environmental conditions, pyrogens, pH, and clarity of solution. You have also Precise temperature control and Energy-efficient heat exchange in your manufacturing plant. During manufacturing, you also invest in the research and development department and quality assurance and quality control labs.
There are some major things which help in the manufacturing of ophthalmic drops such as use active ingredient, excipients, preservatives, measurable quantity should be dispensed. You also know which type of eye drop you manufacture is this single-dose preparation or multiple-dose preparation. Your manufacturing area is hygienic and clean and you use only optimum quality products. After manufacturing covering the vessel with an unbreakable seal and Seal the container. You also have a sealed container for labeling and packing.
Procedure for manufacturing of ophthalmic Drops:
- Enforcing of raw material (Active ingredient, Excipients, preservatives)
- Accurately Weight and measurement quantity should be dispensed
- Disinfected plastic or glass containers for filling drops
- Provide a solution of transportation by adding active ingredients, preservatives, excipients, and other substances
- Make-up volume by adding more conveyance
- Strain this solution for eliminating any foreign and suspended particle
- The clarified solution is filled into the final container
- sterilization involves autoclaving, Filtration, and dry heat sterilization
- Cover the vessel with a breakable seal and Seal the vessel
- Now sealed container goes for labeling and packaging
When you start the manufacturing of ophthalmic drops, you also know what is a requirement of clients. Every client’s requirement is quality standards of products, high effectivity, ensure about products, no side-effects. All of these things clients want from any manufacturer and you fulfill all commitment regarding quality. At its most basic, you also include the expiration date, the period of use, and the date of manufacture on the label.
You have a variety of dosage forms via aseptic processing using either clinical or commercial cleanrooms. Most of the customers observe regulations if all products are manufactured under adherence to GMP, then clients have more trust in you. If you have certification of ISO, WHO, GMP, FDA, that helps to increase the demands of your manufacturing. Your all employees participate in the activities to establish and promote an international quality management system.
You should maintain their integrity throughout their shelf-life when stored at the temperature indicated on the label. Eye drops should be clear and practically free from particles when examined under suitable conditions of visibility. The preparation of ophthalmic drops requires careful consideration of the need for isotonicity. you also ensure that the proper measures are being followed during the manufacturing process to secure the stability and effectiveness of the ophthalmic drops, not to mention the traceability of all of its ingredients.
There are few types of the section you required in manufacturing:
- Washing Section
- Sterilization Section
- Filling Section
- Capping and Sealing Section
- Labeling and Packaging Section
- General Production Section
- Weighing, mixing and Transfer Section
Types of machines and equipment you required in manufacturing:
- Transfer pumps
- Vacuum pumps
- Eye Drop Filling Machine
- Capping and Sealing Machine
- Wax mixing vessel
- mixing vessel/storage vessel
- Dry Heat Sterilization equipment
After we doing deep research regarding the manufacturer process of ophthalmic drops above we share all information and key point. May our blog is helpful for your searches and our key points help in manufacturing eye drops and you will achieve your dream. If you know about ophthalmic and eye drops just contact us or fill the contact form.